Sponsored by National Institutes of Health Clinical Center (CC)
The proposed study aims to evaluate, investigate, and follow-up patients suffering from
acute and chronic liver disease. The study will focus on understanding diseases affecting
Patients participating in the study will first undergo a routine check-up as an outpatient.
They will be asked to provide blood and urine samples for laboratory testing and will
undergo an ultrasound of the liver. Ultrasound examinations use sound waves to determine
the size and texture of the liver. After the initial visit subjects will be requested to
follow-up once a year at the outpatient department for a similar check-up.
Additional tests may be requested throughout the study to provide information for other
research studies and individual consent will be requested. These tests may include liver
biopsies, skin biopsies, and / or specialized blood, plasma, and lymphocyte examinations.
Subjects that qualify for medications presently being studied may be offered the opportunity
to benefit from experimental therapy.
An indefinite number of patients with acute or chronic liver disease will be enrolled in this study. Criteria for selection will be the following:
Age above 2 years, male or female
Evidence of acute or chronic liver disease on evaluation by the outside referring physician
Absence of other significant medical illnesses that might interfere with prolonged follow up evaluation
Willingness to enter the study
There are no specific reasons to exclude any patients from this protocol (exception below for plasmapheresis and lymphapheresis, and genetic analysis of serum samples) as it does not entail significant risk to the patient or excessive clinical burden to the Liver Diseases Branch. Patients who resolve their chronic liver disease, such as patients with chronic hepatitis B who become negative for HBsAg or patients with chronic hepatitis C who become negative for HCV RNA will continue to be followed despite lack of apparent disease or disability. This is to document that clearance of these hepatitis viruses is, indeed, associated with resolution of the liver disease and lack of long-term adverse effects. Because there are data suggesting that chronic HBsAg carriers who become HBsAg-negative and patients with chronic hepatitis C whose liver disease becomes inactive, can still develop long-term consequences of these diseases (especially hepatocellular carcinoma), following such patients is important
Plasmapheresis and lymphapheresis: Patients will have to fulfill the criteria of the NIH Department of Transfusion Medicine regarding lymphapheresis donors. These include age (less that 65 years), weight (greater than 120 pounds), hematocrit (greater than 30 percent), blood pressure (less than 120 diastolic and greater than 90 systolic), and temperature (less than 37.5 degrees C). Because this is a research procedure to obtain reagents and assay materials, only patients who are active and relatively fit (i.e. not disabled from their liver disease) will be asked to undergo this procedure
The only strict exclusion criterion will be active therapy with interferon. The basis for this exclusion was the findings from a retrospective analysis of a recent trial of recombinant human alpha interferon as therapy of chronic hepatitis B. In that study, the "response rate" or rate of clearance of hepatitis B virus with alpha interferon therapy was lower among patients who underwent lymphapheresis during therapy (48 percent) (p less than .01). Lymphapheresis performed before treatment did not seem to affect the outcome of interferon therapy. These findings were unexpected but have led us to avoid both plasmapheresis and lymphapheresis in patients receiving alpha interferon therapy. The reasons why lymphapheresis might interfere with a response to alpha interferon are to known, but probably relate to the importance of an intact, healthy immune system in the process of recovery from a chronic viral infection
Fibroscan: Consecutive adult patients (ages 18 or older) with chronic liver disease who have had a liver biopsy performed within the previous 6 months or who are scheduled to undergo liver biopsy will be eligible for participation in this aspect of the study. Patients with liver biopsies that are inadequate for histological scoring or who have ascites will be excluded from this aspect of the study
Genetic Analysis of Serum Samples: All adult subjects with a Hct of less than 30 and pediatric subjects with a Hct less than 26 will be excluded for phlebotomy that is necessary for isolation of DNA material from the blood cells. Inability to understand or sign informed consent will also exclude patients from this aspect of the study
Study Locations And Contact Information
National Institutes of Health Clinical Center 9000 Rockville Pike, Bethesda Maryland
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